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Completed

NCT Number: NCT06285994

Complications of High Frequency Jet Ventilation

High frequency jet ventilation (HFJV) has been introduced in 1967 as technique allowing ventilation with simultaneous access to the airway for bronchoscopy. Continuous improvement in the technique has led to a large use during interventional bronchoscopy, especially in large centers. However, complications occuring during the use of HFJV are poorly known. In this retrospective cohort study, the charts of all patients who had a bronchoscopy with the use of HFJV between 2019 and 2023 in our hospital will be analyzed. Primary outcome will the description of all complications during HFJV. Complications are defined as:

* Hypoxia: SpO2 < 90% for 1 min * Severe hypoxia: SpO2 < 85% for 1 min * Hemodynamic instability, defined as Arterial pressure < 90/60 * Cardiac arrhythmia * Laryngospasm or bronchospasm * Barotrauma or volutrauma * Need for ICU admission

A model predicting the risk for developing any complication will be developped using 2 mathematical methods:

* a multivariate analysis * a data mining approach

For both approaches, the following variables will be included in the model:

* Age * Gender * Weight * Height * BMI * Smoking * Alcohol consumption * Consumption of Other drugs * ASA class * Obstructive pulmonary disease * Restrictive lung disease * COPD status (1, 2, 3, 4) * Interstitial lung disease * Lung tumor

* Trachea location * Carina location * Bronchial location * Pulmonary or tracheal stenosis * Presence of stridor * Severe stenosis (< 6 mm) * Baseline SpO2 (pre-intervention) * Pre-intervention oxygen requirement Procedure * Duration (min) * Stent placement * Dilation * Laser treatment * Length of hospital stay Lung function tests * FEV1 (forced expiratory volume) * VC (Vital Capacity) * FEV1/VC (Tiffeneau ratio) * CPT (total lung capacity) * DLCO (carbon monoxide diffusion)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Universitaire de Bruxelles - Hôpital erasme

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients who underwent a bronchoscopy with the use of high frequency jet ventilation between January 1st, 2019 and December 31st, 2023 at Erasme University Hospital, Brussels

Exclusion criteria

  • Incomplete medical chart
  • Patient who expressed their opposition to the use of their medical data

Treatment and study plan

High frequency jet ventilation

Procedure

Use of high frequency jet ventilation during bronchoscopy

Primary outcomes

  1. Occurence of complications

    Time frame: 6 hours

    The occurence (%) of complications of HFJV will be analyzed. Definition of complications is one or more of the following events:

    • Hypoxia: SpO2 < 90% for 1 min (%)
    • Severe hypoxia: SpO2 < 85% for 1 min (%)
    • Hemodynamic instability, defined as Arterial pressure < 90/60 (%)
    • Cardiac arrhythmia (%)
    • Laryngospasm or bronchospasm (%)
    • Barotrauma or volutrauma (%)
    • Need for ICU admission (%)

    Complications will be reported as overall complications (%) defined as the occurence of one or more of the listed events.

    Frequency of single events will be reported separately (%). Descriptive statistics ( %, mean, standard deviation, median, interquartile range) will be used as appropriate.

Secondary outcomes

  1. Prediction model of complications

    Time frame: 6 hours

    A model predicting the risk for developing any complication will be developped using 2 mathematical methods:

    • a multivariate analysis
    • a data mining approach

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Complications of High Frequency Jet Ventilation During Bronchoscopy - a Retrospective Cohort Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 29, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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